FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
VISUWELL SYPHILIS ANTIGEN
K Number: K910487
·
Decision Jun 24, 1991
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
34
Applicant Total
4
Review Days
138
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Basic Information
- Device Name
- VISUWELL SYPHILIS ANTIGEN
- K Number
- K910487
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Adi Diagnostics, Inc.
- Date Received
- February 6, 1991
- Decision Date
- June 24, 1991
- Product Code
- LIP
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | FDA class 2 | Microbiology |
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